FREEDOM OF INFORMATION SUMMARY

Size: px
Start display at page:

Download "FREEDOM OF INFORMATION SUMMARY"

Transcription

1 Date of Approval Letter: FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA VALBAZEN (albendazole)...for the removal and control of a variety of internal parasites common in cattle and sheep. Sponsored by: Pfizer, Inc.

2 General Information I. GENERAL INFORMATION NADA Number: Sponsor: Established Name: Pfizer, Inc. 235 East 42d Street New York, New York albendazole Trade Name: VALBAZEN Pharmacological category: How Supplied: Label claim of the Amount of Active Ingredient(s): Marketing Status: Species: Effect of the Supplement: antiparasitic 500- and 1000-mL bottles 11.36% suspension (113.6 mg/ml) over-the-counter sheep and cattle The supplement adds sheep uses approved for a less concentrated suspension to labeling for an approved, more concentrated formulation. II. INDICATIONS FOR USE For the removal and control of the following parasites in cattle and sheep Parasite Cattle Sheep Liver Flukes Fasciola hepatica Fasciola hepatica, Fascioloides magna Tapeworms (heads and segments) Stomach Worms (adults and Moniezia benedeni, M. expansa Brown Stomach Worms, including 4th stage inhibited larvae (Ostertagia ostertagi), Barberpole Worms (Haemonchus contortus, H. placei), Small Stomach Worms (Trichostrongylus axei) Common Tapeworms (Moniezia expansa), Fringed Tapeworms (Thysanosoma actinioides) Brown Stomach Worms (Ostertagia circumcincta, Marshallagia marshalli), Barberpole Worms (Haemonchus contortus), Small Stomach Worms (Trichostrongylus axei) NADA Page 1

3 Dosage Form Intestinal Worms (adults and Intestinal Worms (adults and Lungworms (adults and 4 th stage larvae) Lungworms (adults and larval stages) Thread-Necked Intestinal Worms (Nematodirus spathiger, N. helvetianus), Small Intestinal Worms (Cooperia oncophora, C. punctata) Hookworms (Bunostomum phlebotomum), Bankrupt Worms (Trichostrongylus colubriformis), Nodular Worms (Oesophagostomum radiatum) Dictyocaulus viviparus Thread-Necked Intestinal Worms (Nematodirus spathiger, N. filicollis ), Cooper's Worm (Cooperia oncophora), Bankrupt Worms (Trichostrongylus colubriformis), Nodular Worms (Oesophagostomum columbianum), Large-Mouth Bowel Worms (Chabertia ovina) Dictyocaulus filaria III. DOSAGE FORM, ROUTE OF ADMINISTRATION, AND DOSAGE A. Dosage Form: suspension B. Route of Administration: oral, as a drench C. Recommended Dosage: 7.5 mg/kg body weight (3.4 mg/lb; sheep) or 10 mg/kg body weight (4.45 mg/lb; cattle). IV. TARGET ANIMAL SAFETY AND EFFECTIVENESS Target animal safety and effectiveness data for albendazole in sheep and cattle were accepted under original NADA & NADA The increased albendazole concentration is not expected to pose any specific risk hazard to sheep. The actual amount of drug administered to sheep per unit body weight remains unchanged. CVM has concluded that the two formulations should perform in an identical manner when administered to sheep. Accordingly, the sponsor s request for waiver of in vivo study requirement has been granted, and no additional studies are required to support the approval of the 11.36% oral suspension of albendazole for sheep. NADA Page 2

4 Human Safety VI. HUMAN SAFETY This supplemental NADA did not require new human safety studies. The basic toxicology and residue chemistry studies that support the use of albendazole in cattle and sheep are summarized in the FOI Summaries for the original approvals of albendazole under NADA and NADA Based on the original NADAs, the following has been assigned to this product: a. Acceptable Daily Intake: The Acceptable Daily Intake (ADI) of 5 µg/kg body weight/day was assigned to cattle and sheep on the basis of the toxicology studies. b. Safe Concentrations of Residues: The safe concentrations of albendazole residues in edible tissues of sheep and cattle were established at 0.6 part per million (ppm) for sheep and cattle muscle, 3.0 ppm for liver, kidney and fat tissue of sheep, 1.2 ppm for cattle liver, 1.8 ppm for cattle kidney, and 2.4 ppm for cattle fat. c. Tolerances of Marker Residue: Residue and metabolism studies established 0.2 ppm and 0.25 ppm as the tolerances for residues of albendazole 2-aminosulfone (the marker residue) in cattle liver (target tissue) and sheep liver, respectively. d. Assignment of a muscle tolerance: A tolerance of 0.05 ppm albendazole 2-aminosulfone is assigned for cattle and sheep muscle following a review of the residue studies conducted with albendazole in those species. The total residue studies conducted with 14 C-albendazole show that total residues in muscle are expected to be in the range of 1 ppm to 4 ppm at 1 day after dosing under the approved conditions of use and that those residues deplete to 0.06 ppm or less (10% of the 0.6 ppm muscle safe concentration) by 3 to 4 days after dosing. Because of the rapid depletion of total residues from muscle, muscle tissue was not assayed in any of the nonradiolabeled (withdrawal) residue studies in either NADA or NADA Likewise, the metabolites present in muscle were not profiled. With a minimum of residue data available, the muscle tolerance value is estimated with consideration given to the metabolite profile data in liver of each species and to the capabilities of the determinative analytical method for residues in liver. A concentration of 0.05 ppm of the marker residue is assigned as the muscle tolerance because it represents a conservative estimate of the tolerance, and it is above the ppm limit of quantitation of the determinative assay as validated in liver. The 0.05 ppm muscle tolerance makes it possible to identify cattle or sheep that have been marketed within 1 to 3 days after treatment with albendazole. As withdrawal times approaching the preslaughter withdrawal periods of 27 days for cattle and 7 days for sheep, the marker residue is unlikely to be detected in muscle tissue. NADA Page 3

5 VII. AGENCY CONCLUSIONS The information submitted in support of this application comply with the requirements of Section 512 of the Federal Food, Drug, and Cosmetic Act and implementing regulations at Part 514 of Title 21, Code of Federal Regulations (21 CFR 514) and indicate that albendazole oral suspension (11.36% ) is safe and effective in sheep for the conditions of the use described in labeling. Although no new toxicology or residue chemistry studies were submitted with this supplement, CVM has used this opportunity to assign a tolerance of 0.05 ppm albendazole 2-aminosulfone for residues of albendazole in cattle and sheep muscle. The pre-slaughter withdrawal periods of 27 days in cattle and 7 days in sheep remain unchanged. There is reasonable certainty that the directions for use on labeling can and will be followed in practice. Accordingly, the Agency has concluded that this product shall retain over-the-counter marketing status. In accordance with 21 CFR (b)(2), this is a category II change which did not require a reevaluation of the safety and effectiveness data in the parent application. The Agency has carefully considered the potential environmental effects of this action and has concluded that the action qualifies for a categorical exclusion from the requirement to prepare an environmental assessment in accordance with 21 CFR 25.33(a)(1). VIII. APPROVED LABELING (attached) Facsimile label. 1-liter bottle

FREEDOM OF INFORMATION SUMMARY

FREEDOM OF INFORMATION SUMMARY Date of Approval: June 30, 2004 FREEDOM OF INFORMATION SUMMARY SUPPLEMENTAL NEW ANIMAL DRUG APPLICATION NADA 141-095 (doramectin) To extend the period of persistent effect for Cooperia oncophora and Dictyocaulus

More information

FREEDOM OF INFORMATION SUMMARY

FREEDOM OF INFORMATION SUMMARY Date of Approval Letter: FREEDOM OF INFORMATION SUMMARY NEW ANIMAL DRUG APPLICATION NADA 141-148 Combination of DECCOX AND RUMENSIN in Cattle Feed (decoquinate and monensin) For the prevention of coccidiosis

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Valbazen 100 mg/ml Total Spectrum Wormer 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Albendazole

More information

Cydectin. Fort Dodge PRODUCT DESCRIPTION

Cydectin. Fort Dodge PRODUCT DESCRIPTION Cydectin Fort Dodge moxidectin Injectable Solution for Beef and Nonlactating Dairy Cattle Antiparasitic Contains 10 mg moxidectin/ml Not for use in female dairy cattle of breeding age, veal calves, and

More information

FREEDOM OF INFORMATION SUMMARY

FREEDOM OF INFORMATION SUMMARY Date of Approval: FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION LONGRANGE (eprinomectin) Extended-Release Injectable Parasiticide for the treatment and control of internal and external

More information

INTERNAL PARASITES OF SHEEP AND GOATS

INTERNAL PARASITES OF SHEEP AND GOATS 7 INTERNAL PARASITES OF SHEEP AND GOATS These diseases are known to occur in Afghanistan. 1. Definition Parasitism and gastrointestinal nematode parasitism in particular, is arguably the most serious constraint

More information

SUMMARY OF THE PRODUCT CHARACTERISTICS

SUMMARY OF THE PRODUCT CHARACTERISTICS SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Animec Super Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance(s):

More information

FEEDLOT PERFORMANCE, HEALTH, AND CARCASS CHARACTERISTICS OF BEEF HEIFERS TREATED WITH CYDECTIN OR DECTOMAX AT PROCESSING

FEEDLOT PERFORMANCE, HEALTH, AND CARCASS CHARACTERISTICS OF BEEF HEIFERS TREATED WITH CYDECTIN OR DECTOMAX AT PROCESSING Beef Cattle Research 2005 FEEDLOT PERFORMANCE, HEALTH, AND CARCASS CHARACTERISTICS OF BEEF HEIFERS TREATED WITH CYDECTIN OR DECTOMAX AT PROCESSING R. L. Hale, D. Gray 1, and R. Armendariz 2 Summary Two

More information

Fasimec Cattle Oral Flukicide and Broad Spectrum Drench

Fasimec Cattle Oral Flukicide and Broad Spectrum Drench Product name: Fasimec Cattle Oral Flukicide and Broad Spcctrum Drench Page: 1 of 10 Display box front panel 5 L gun pack only CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orafluke 5% w/v Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of suspension contains: Active Substances

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zearl 10 mg/ml Solution for Injection for Cattle and Sheep. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bimectin 1% w/v Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances Ivermectin 1.0 % w/v For

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Duotech Oral Suspension for Sheep. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Oxfendazole 25 mg/ml Closantel

More information

SUMMARY OF PRODUCTS CHARACTERISTICS

SUMMARY OF PRODUCTS CHARACTERISTICS SUMMARY OF PRODUCTS CHARACTERISTICS Revised: 15 January 2009 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tramazole 2.5% w/v SC Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance

More information

Cydectin Pour-On for Cattle

Cydectin Pour-On for Cattle Cydectin Pour-On for Cattle moxidectin Pour-On for Beef and Dairy Cattle Antiparasitic Contains 5 mg moxidectin/ml For Treatment of Infections and Infestations Due to Internal and External Parasites of

More information

Clozanox 150. Closantel Oral Solution. Protect your live stock with. COMPOSITION: Each ml contains: Closantel 150 mg

Clozanox 150. Closantel Oral Solution. Protect your live stock with. COMPOSITION: Each ml contains: Closantel 150 mg Clozanox 150 Closantel Oral Solution COMPOSITION: Closantel 150 mg The Gold standard Control & treatment of Liver flukes, gastro intestinal round worms & ectoparasites. In Cattle, Buffalo, Sheep, Goat,

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Supaverm Oral Suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: % w/v Closantel (as closantel sodium

More information

Human Food Safety of Veterinary Drugs. Bettye K. Walters, DVM

Human Food Safety of Veterinary Drugs. Bettye K. Walters, DVM Human Food Safety of Veterinary Drugs Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 50 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Closantel

More information

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine MERIAL LTD. USA Product Label http://www.vetdepot.com 3239 SATELLITE BLVD., DULUTH, GA, 30096 Telephone: 888-637-4251 Website: www.merial.com IVOMEC 1% INJECTION FOR CATTLE AND SWINE Merial (ivermectin)

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cydectin 1% w/v Injectable Solution for Sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Moxidectin Excipients

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/MRL/728/00-FINAL April 2000 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS STREPTOMYCIN AND

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orafluke 10% w/v Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substances per ml Fenbendazole 100 mg Rafoxanide

More information

FREEDOM OF INFORMATION (FOI) SUMMARY

FREEDOM OF INFORMATION (FOI) SUMMARY Date of Approval: March 25, 2003 FREEDOM OF INFORMATION (FOI) SUMMARY Acepromazine Maleate Injection 10 mg/ml Tranquilizer for use in dogs, cats, and horses ANADA 200-319 Phoenix Scientific, Inc. 3915

More information

FREEDOM OF INFORMATION SUMMARY

FREEDOM OF INFORMATION SUMMARY Date of Approval: JAN 2 4 FREEDOM OF NFORMATON SUMMARY SUPPLEMENTAL NEW ANMAL DRUG APPLCATON NADA 110-048 VALBAZEN Albendazole 11.36% suspension Non-lactating goats "...for the treatment of adult liver

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLVIX 25 mg/ml oral solution for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains

More information

Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle, sheep and goats. Active substance: Eprinomectin mg

Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle, sheep and goats. Active substance: Eprinomectin mg 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Eprinex Multi 5 mg/ml pour-on for beef and dairy cattle, sheep and goats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Eprinomectin...

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE European Medicines Agency Veterinary Medicines and Inspections EMEA/CVMP/211249/2005-FINAL July 2005 COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE DIHYDROSTREPTOMYCIN (Extrapolation to all ruminants)

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 15 January 2013 EMA/CVMP/914694/2011 Committee for Medicinal Products for Veterinary Use (CVMP) European public MRL assessment report (EPMAR) Fenbendazole (extension to chicken and extrapolation to all

More information

For Beef Cattle, Dairy Cattle and Deer. For the control & treatment of internal and external parasites in cattle and deer

For Beef Cattle, Dairy Cattle and Deer. For the control & treatment of internal and external parasites in cattle and deer For Beef Cattle, Dairy Cattle and Deer For the control & treatment of internal and external parasites in cattle and deer ACTIVE INGREDIENT CONCENTRATION 10g/L abamectin INDICATIONS Cattle: Roundworms,

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Acomec 10 mg/ml Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: Active

More information

European Public MRL assessment report (EPMAR)

European Public MRL assessment report (EPMAR) 18 March 2016 EMA/CVMP/619817/2015 Committee for Medicinal Products for Veterinary Use European Public MRL assessment report (EPMAR) Gentamicin (all mammalian food producing species and fin fish) On 3

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Chanimec 10 mg/ml solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Ivermectin

More information

PROTECT HERD PERFORMANCE

PROTECT HERD PERFORMANCE (eprinomectin) 99.9% Effective against the major species and stages of parasites days meat withdrawal milk discard SAME active ingredient and dosing regimen as Eprinex (eprinomectin) PROTECT HERD PERFORMANCE

More information

Responsible Use of Veterinary Products. Bettye K. Walters, DVM

Responsible Use of Veterinary Products. Bettye K. Walters, DVM Responsible Use of Veterinary Products Bettye K. Walters, DVM Bettye.walters@fda.hhs.gov Pertinent International Resources Organization for Economic Co-Operation and Development (OECD) Understanding the

More information

[Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

[Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS [Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEOPRINIL POUR-ON 5 mg/ml pour-on solution for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

[Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

[Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS [Version 7.3.2, 10/2011] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NEOPRINIL POUR-ON 5 mg/ml pour-on solution for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

More information

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Closiver 5 mg/ml/125 mg/ml Solution for Injection for Cattle and Sheep (UK & IE) Closamectin 5 mg/ml/125 mg/ml Solution for

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:

More information

Superior sheep parasite control. But don t take our word for it.

Superior sheep parasite control. But don t take our word for it. FROM THE PEOPLE WHO BROUGHT YOU IVOMEC Merial (formerly MSD AGVET) has been providing innovative animal health products to Australian agriculture for over forty years. In the early sixties the introduction

More information

Veterinary Medicinal Products (dips, injectables, pour ons and sprays) authorised in the UK for use against ectoparasites in sheep

Veterinary Medicinal Products (dips, injectables, pour ons and sprays) authorised in the UK for use against ectoparasites in sheep Veterinary Medicinal Products (dips, injectables, pour ons and sprays) authorised in the UK for use against ectoparasites in sheep (Products which are no longer authorised may be used until the expiry

More information

EC Prevent Worms...to Increase Sheep Profits

EC Prevent Worms...to Increase Sheep Profits University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Historical Materials from University of Nebraska- Lincoln Extension Extension 1981 EC81-1905 Prevent Worms...to Increase

More information

Fenbender 100 CAUTION. Oral Anthelmintic for cattle & horses. ACTIVE CONSTITUENT: 100 g/l FENBENDAZOLE

Fenbender 100 CAUTION. Oral Anthelmintic for cattle & horses. ACTIVE CONSTITUENT: 100 g/l FENBENDAZOLE Apparent Pty Ltd Suite G.08, 762 Toorak Road, Glen Iris VIC 3146, PO Box 3092 Cotham PO Kew Vic 3101 Phone 03 9822 1321 Mobile 0411 227 338 APVMA Approval No: 69913/62050 CAUTION KEEP OUT OF REACH OF CHILDREN

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Cydectin 1% w/v Solution for Injection for cattle

SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Cydectin 1% w/v Solution for Injection for cattle SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cydectin 1% w/v Solution for Injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substances:

More information

Parasite Management for Small Ruminants

Parasite Management for Small Ruminants Parasite Management for Small Ruminants Slides contributed by tatiana Stanton, Steve Hart, Betsy Hodge, Katherine Petersson, Susan Schoenian, Mary Smith DVM and James Weber DVM and many others Part 1.

More information

Parasite control in a class of its own

Parasite control in a class of its own Cydectin (moxidectin) PourOn PourOn Parasite control in a class of its own The true cost of parasites How long would it take you to notice if your cattle had a parasite infection? Chances are that by the

More information

Parasites in Sheep Flocks

Parasites in Sheep Flocks Parasites in Sheep Flocks 1 WHAT IS NEW IN PARASITE CONTROL FOR SHEEP FLOCKS? Drew E. Hunnisett, DVM Honeywood and Warder Veterinary Services 132 Commerce Park Drive, Unit N Barrie, Ontario L4N 8W8 705

More information

YOUR PASTURE. GET MORE PROFIT out of

YOUR PASTURE. GET MORE PROFIT out of GET MORE PROFIT out of YOUR PASTURE. The benefits of deworming cows with LONGRANGE (eprinomectin) with up to 150 days of parasite control in a single dose. 1,2 FOCUSING YOUR DEWORMING PROTOCOL JUST ON

More information

SUMMARY OF THE PRODUCT CHARACTERISTICS

SUMMARY OF THE PRODUCT CHARACTERISTICS SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Animec 5 mg/ml Pour-on Solution for Cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Ivermectin 5 mg/ml

More information

Guidance for Industry

Guidance for Industry Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors

More information

Rx, For use by or on the order of a licensed veterinarian.

Rx, For use by or on the order of a licensed veterinarian. A. General Information NADA Number: 140-915 Sponsor: Generic Name of Drug: Trade Name: Marketing Status: Novartis Animal Health Post Office Box 18300 Greensboro, NC 27419 Milbemycin Oxime INTERCEPTOR Flavor

More information

PARASITOLOGY IN 2020 Where will we stand? EU Framework Programmes PARASOL & GLOWORM & PARAVAC

PARASITOLOGY IN 2020 Where will we stand? EU Framework Programmes PARASOL & GLOWORM & PARAVAC PARASITOLOGY IN 2020 Where will we stand? EU Framework Programmes PARASOL & GLOWORM & PARAVAC All grazing ruminants are infected with helminths, however, only some need to be treated Production diseases

More information

Summary of Product Characteristics

Summary of Product Characteristics Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flukiver 5% w/v Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance Closantel (as Clostanel sodium)

More information

For the treatment and prevention of infections caused by:

For the treatment and prevention of infections caused by: SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYDECTIN 0.1 % W/V ORAL SOLUTION for sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance Moxidectin

More information

In 2013 The FDA Approved The Use Of Advantage Multi For The Prevention Of Heartworms And Fleas On Us Ferrets Too!

In 2013 The FDA Approved The Use Of Advantage Multi For The Prevention Of Heartworms And Fleas On Us Ferrets Too! In 2013 The FDA Approved The Use Of Advantage Multi For The Prevention Of Heartworms And Fleas On Us Ferrets Too! Because our hearts are so small, when we contract heartworms, it only takes one or two

More information

EC Prevent Worms to Increase Sheep Profits

EC Prevent Worms to Increase Sheep Profits University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Historical Materials from University of Nebraska- Lincoln Extension Extension 1964 EC64-1905 Prevent Worms to ncrease Sheep

More information

Guidance for Industry

Guidance for Industry Guidance for Industry #213 New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food- Producing Animals: Recommendations for Drug Sponsors

More information

They're not all the same: Why FDA approval of animal drugs matters

They're not all the same: Why FDA approval of animal drugs matters They're not all the same: Why FDA approval of animal drugs matters Elizabeth Luddy, DVM Deputy Director, Office of New Animal Drug Evaluation Center for Veterinary Medicine US Food and Drug Administration

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines Evaluation Unit EMEA/MRL/389/98-FINAL July 1998 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS ENROFLOXACIN (extension to

More information

The parasites and parasitic diseases of cattle

The parasites and parasitic diseases of cattle Louisiana State University LSU Digital Commons LSU Agricultural Experiment Station Reports LSU AgCenter 1948 The parasites and parasitic diseases of cattle W R. Odson Follow this and additional works at:

More information

ANZSDP issued May 2009-Hutchinson GW. Nematode Parasites of Small Ruminants, Camelids and Cattle

ANZSDP issued May 2009-Hutchinson GW. Nematode Parasites of Small Ruminants, Camelids and Cattle ANZSDP issued May 2009-Hutchinson GW Nematode Parasites of Small Ruminants, Camelids and Cattle 5 Diagnosis with Emphasis on Anthelmintic Efficacy and Resistance Testing 10 15 Gareth W Hutchinson formerly

More information

CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS FOR ANIMAL TREATMENT ONLY DECTOMAX. Injectable endectocide. DORAMECTIN 10 mglml

CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS FOR ANIMAL TREATMENT ONLY DECTOMAX. Injectable endectocide. DORAMECTIN 10 mglml Date: 22 September 2011 Page 1 2011 Reason: Category 14- Addition of In-use shelf life and ESI Statement IMMEDIATE CONTAINER (Bottle) Front Panel CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS

More information

European public MRL assessment report (EPMAR)

European public MRL assessment report (EPMAR) 11 November 2013 EMA/CVMP/561830/2010 Committee for Medicinal Products for Veterinary Use European public MRL assessment report (EPMAR) Neomycin (including framycetin) (All food producing species) On 29

More information

A survey of the helminth parasites of cattle and sheep in Utah Valley

A survey of the helminth parasites of cattle and sheep in Utah Valley Great Basin Naturalist Volume 30 Number 3 Article 2 9-30-1970 A survey of the helminth parasites of cattle and sheep in Utah Valley J. Carl Fox Montana State University, Bozeman, Montana Ferron L. Andersen

More information

Avermectins, New Family of Potent Anthelmintic Agents: Efficacy of the Bla Component

Avermectins, New Family of Potent Anthelmintic Agents: Efficacy of the Bla Component ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, Mar. 1979, p. 372-378 0066-4804/79/03-0372/07$02.00/0 Vol. 15, No. 3 Avermectins, New Family of Potent Anthelmintic Agents: Efficacy of the Bla Component J. R. EGERTON,*

More information

In cattle: For the treatment of infections with the following parasites

In cattle: For the treatment of infections with the following parasites 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Kilo-mec 0.5 % Pour-On Solution for Cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: Active substance Ivermectin 5 mg Excipients

More information

Training Module No 2

Training Module No 2 Training Module No 2 Theory 1. Heartwater 2. 5 point check for internal parasites 3. Checking for signs of anaemia 4. Roundworm 5. Taking temperature and weighing your goat Property of Abafuyi Media Training

More information

Maximum Residue Limits (MRLs) and Consumer safety. Presented by: Isaura Duarte, European Medicines Agency

Maximum Residue Limits (MRLs) and Consumer safety. Presented by: Isaura Duarte, European Medicines Agency Maximum Residue Limits (MRLs) and Consumer safety Presented by: Isaura Duarte, European Medicines Agency Overview Consumer safety and MRLs Procedure for the establishment of MRLs in the EU Data requirements

More information

Treatment Strategies to control Parasitic Roundworms In Cattle

Treatment Strategies to control Parasitic Roundworms In Cattle Treatment Strategies to control Parasitic Roundworms In Cattle Dave Bartley Which roundworms are most likely to cause problems? Scientific name Common name Disease Ostertagia ostertagi Brown stomach worm

More information

Parasite control in beef and dairy cattle

Parasite control in beef and dairy cattle Vet Times The website for the veterinary profession https://www.vettimes.co.uk Parasite control in beef and dairy cattle Author : Louise Silk Categories : Farm animal, Vets Date : August 22, 2016 Control

More information

FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats

FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats Date of change: 12 February 2004 Page: 1 of 12 Bottle, front panel READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats Active

More information

Residues. Mike Apley, DVM, PhD

Residues. Mike Apley, DVM, PhD Residues Mike Apley, DVM, PhD Residues: It s Black and White Residues occur when detected concentrations of the marker residue are above the approved tolerance for that drug in that tissue. Residues are

More information

Review of the Parasites of Large Animals

Review of the Parasites of Large Animals LABORATORY Laboratory 10 Pg. 1 10 Introduction: Review of the Parasites of Large Animals In labs 2 through 10 we presented you with the various parasites of veterinary importance in a taxonomic manner.

More information

Medically Important Antimicrobials in Animal Agriculture. Sheep

Medically Important Antimicrobials in Animal Agriculture. Sheep Medically Important Antimicrobials in Animal Agriculture Sheep Mike Murphy DVM, JD, Ph.D., DABVT, DABT Veterinary Medical Officer Office of the Director Center for Veterinary Medicine FDA Outline Take

More information

Scientific Discussion post-authorisation update for Rheumocam extension X/007

Scientific Discussion post-authorisation update for Rheumocam extension X/007 5 May 2011 EMA/170257/2011 Veterinary Medicines and Product Data Management Scientific Discussion post-authorisation update for Rheumocam extension X/007 Scope of extension: addition of 20 mg/ml solution

More information

Control of Helminth Parasites in Cow Calf Operations in the Southern United States

Control of Helminth Parasites in Cow Calf Operations in the Southern United States Control of Helminth Parasites in Cow Calf Operations in the Southern United States Thomas M. Craig, Ph.D. Department of Veterinary Pathobiology, Texas A&M University, College Station, TX To control parasitic

More information

Name INN Strength Pharmaceutical form. Distocur Oxyclozanide 34 mg/ml Oral suspension Cattle, sheep

Name INN Strength Pharmaceutical form. Distocur Oxyclozanide 34 mg/ml Oral suspension Cattle, sheep Annex I List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, applicants/marketing authorisation holders in the Member States 1/16

More information

ANNEX I. Marketing Authorisation Holder (Name and address): Reference Member State:

ANNEX I. Marketing Authorisation Holder (Name and address): Reference Member State: ANNEX I LIST OF THE PHARMACEUTICAL FORMS, STRENGTHS, ROUTES OF ADMINISTRATION, PACKAGING AND PACKAGE SIZES OF THE VETERINARY MEDICINAL PRODUCT IN THE MEMBER STATES ANNEX I Marketing Authorisation Holder

More information

[amended May 5, 2005]

[amended May 5, 2005] The FARAD Newsletter is an electronic publication from the Food Animal Residue Avoidance Databank (FARAD) for veterinarians, animal scientists, extension specialists and the regulatory community. Issue

More information

In sheep: M oxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:

In sheep: M oxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of: SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cydectin 1% w/v Injectable Solution for Sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active substance:

More information

Large Animal Topics in Parasitology for the Veterinary Technician Jason Roberts, DVM This presentation is designed to review the value veterinary

Large Animal Topics in Parasitology for the Veterinary Technician Jason Roberts, DVM This presentation is designed to review the value veterinary Large Animal Topics in Parasitology for the Veterinary Technician Jason Roberts, DVM This presentation is designed to review the value veterinary technicians can add to mixed or large animal practices

More information

Why Do Cattlemen De-worm?

Why Do Cattlemen De-worm? Extended-Release Injection Available from Veterinarians by Prescription Hoyt Cheramie, DVM, MS,DACVS Large Animal Veterinary Services Merial Limited 1 2 Seven Factors that Drive Profit in Cow/Calf 11 Weaned

More information

Antibiotics and Antiparasiticals. Flexible solutions for germ s control in poultry and livestock industry!

Antibiotics and Antiparasiticals. Flexible solutions for germ s control in poultry and livestock industry! Antibiotics and Antiparasiticals. Flexible solutions for germ s control in poultry and livestock industry! ABOUT US Well known on the Romanian market DELOS Medica has consolidated its position during these

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Distocur 34 mg/ml Oral suspension for cattle. Distocur.vet 34 mg/ml Oral suspension for cattle. (DK, NO, SE) 2.

More information

Control of Internal Parasites in Sheep

Control of Internal Parasites in Sheep Revised 1995 Sheep PUBLICATION 410-027 Control of Internal Parasites in Sheep W. Dee Whittier, Anne Zajac, and Steven H. Umberger* Introduction Internal parasites, or worms, cause economic and production

More information

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS

COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Inspections EMEA/MRL/816/02-FINAL January 2002 COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS NEOMYCIN SUMMARY REPORT

More information

Clinical and hematological study in sheep infected with gastrointestinal parasites in Mosul

Clinical and hematological study in sheep infected with gastrointestinal parasites in Mosul ( - ) ( ) % Ostertagia circumcincta %, Marshallagia marshalli (% ) %, Muellerius capillaries %, Dicyocaulus filaria) %, Lung worms %, %, Nematodirus spp. %, Haemonchus contortus %, Trichostrongylus spp.

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HALOCUR 0.5 mg/ml oral solution for calves 2. Qualitative and quantitative composition Active substance Halofuginone

More information

Managing Internal Parasites in Small Ruminants. Dan Macon UC Cooperative Extension September 14, 2018

Managing Internal Parasites in Small Ruminants. Dan Macon UC Cooperative Extension September 14, 2018 Managing Internal Parasites in Small Ruminants Dan Macon UC Cooperative Extension September 14, 2018 Overview What are the major parasites that can infect small ruminants in California? Symptoms of infection

More information

Internal Roundworm Parasites of Beef Cattle and their Control: A Canadian perspective

Internal Roundworm Parasites of Beef Cattle and their Control: A Canadian perspective Roundworm Parasites of Beef Cattle and their Control: A Canadian perspective John Gilleard 1 and Tara Mulhern Davidson 2 1Faculty of Veterinary Medicine, University of Calgary. 2. Beef Cattle Research

More information

Multiplexed-tandem PCR (MT-PCR) assay to detect and differentiate gastrointestinal nematodes of alpacas

Multiplexed-tandem PCR (MT-PCR) assay to detect and differentiate gastrointestinal nematodes of alpacas Rashid et al. Parasites & Vectors (2018) 1:370 https://doi.org/10.1186/s13071-018-2963-9 SHORT REPORT Open Access Multiplexed-tandem PCR (MT-PCR) assay to detect and differentiate gastrointestinal nematodes

More information

New Animal Drugs; Change of Sponsor s Address; Monensin; Spinosad; Tilmicosin

New Animal Drugs; Change of Sponsor s Address; Monensin; Spinosad; Tilmicosin This document is scheduled to be published in the Federal Register on 10/04/2012 and available online at http://federalregister.gov/a/2012-24475, and on FDsys.gov 4160-01-P DEPARTMENT OF HEALTH AND HUMAN

More information

9081V 9082V 9032V 9291V 9310V 9321V V

9081V 9082V 9032V 9291V 9310V 9321V V Products: Veterinary Feed Directives (VFD) As of Jan 1, 2017, some feed-grade antibiotics require a veterinary feed directive issued by a licensed veterinarian and will be subject to the following restriction:

More information

Quantification of Albendazole in Dewormer Formulations in the Kenyan market

Quantification of Albendazole in Dewormer Formulations in the Kenyan market Available online at www.pelagiaresearchlibrary.com Advances in Applied Science Research, 2011, 2 (2): 9-13 Quantification of Albendazole in Dewormer Formulations in the Kenyan market H.N. Wanyika*, P G

More information

Cattle and Swine Parasites

Cattle and Swine Parasites Ostertagia ostertagi Brown stomach worm 6-10 mm Larvae destroy gastric glands Severe diarrhea & weight loss Tx: Albendazole, Fenbendazole, Ivermectin, Moxidextin N.B.: Ostertagia is the most important

More information

RECOVERY OF NEMATODES FROM RUMINANTS BY MIGRATION FROM GASTRO-INTESTINAL INGESTA AND MUCOSA GELLED IN AGAR: PRELIMI NARY REPORT

RECOVERY OF NEMATODES FROM RUMINANTS BY MIGRATION FROM GASTRO-INTESTINAL INGESTA AND MUCOSA GELLED IN AGAR: PRELIMI NARY REPORT Onderstepoort J. vet. Res. 4, 9-8 (1978) RECOVERY OF NEMATODES FROM RUMINANTS BY MIGRATION FROM GASTRO-INTESTINAL INGESTA AND MUCOSA GELLED IN AGAR: PRELIMI NARY REPORT J. A. VANWYK and H. M. GERBER, Veterinary

More information

COWS. Control Of Worms Sustainably SUSTAINABLE WORM CONTROL STRATEGIES FOR CATTLE. Prof M.A.Taylor BVMS PhD MRCVS DipEVPC DipECSRHM CBiol MSB

COWS. Control Of Worms Sustainably SUSTAINABLE WORM CONTROL STRATEGIES FOR CATTLE. Prof M.A.Taylor BVMS PhD MRCVS DipEVPC DipECSRHM CBiol MSB COWS Control Of Worms Sustainably SUSTAINABLE WORM CONTROL STRATEGIES FOR CATTLE Prof M.A.Taylor BVMS PhD MRCVS DipEVPC DipECSRHM CBiol MSB A Technical Manual for Veterinary Surgeons and Advisors 2 Supporting

More information

THE IDENTIFICATION OF GASTROINTESTINAL NEMATODES SPECIES IN SHEEP IN FIVE LOCALITIES FROM TIMIS COUNTY

THE IDENTIFICATION OF GASTROINTESTINAL NEMATODES SPECIES IN SHEEP IN FIVE LOCALITIES FROM TIMIS COUNTY THE IDENTIFICATION OF GASTROINTESTINAL NEMATODES SPECIES IN SHEEP IN FIVE LOCALITIES FROM TIMIS COUNTY D. INDRE¹, GH. DĂRĂBU޹, I. OPRESCU¹, S. MORARIU¹, NARCISA MEDERLE¹, M.S. ILIE¹, D.N. MĂNDIłĂ² ¹ Department

More information

Redacted for Privacy

Redacted for Privacy AN ABSTRACT OF THE THESIS OF Laura S. Richards for the degree of Master of Science in Veterinary Science presented on July 18. 1986. Title: The Anthelmintic Activity of SCH 32481 (Netobimin2) Against Gastrointestinal

More information

Gastrointestinal nematodes

Gastrointestinal nematodes PARASITOLOGY Parasites are one of the most important considerations in the overall health of the Alpaca. It is imperative to learn what are the common parasites that are common to your particular area

More information